Cimzia(R) (certolizumab pegol) Provides Long-Term Remission and Response Rates in...

Cimzia(R) (certolizumab pegol) Provides Long-Term Remission and Response Rates
in Infliximab-Refractory Crohn's Patients

Cimzia(R) shows duration of response up to week 26 in moderate to severe
Crohn's patients who failed the intravenous infusion treatment infliximab.

CHICAGO, June 1 /PRNewswire/ -- New data from the WELCOME study presented by
UCB at the Digestive Disease Week meeting demonstrate that Cimzia(R)
(certolizumab pegol) provides sustained symptom improvement with stable dosing
through week 26 for adult patients suffering from moderate to severe Crohn's
disease (CD) who are intolerant or no longer responding to Remicade(R)
(infliximab). Cimzia(R) is approved for reducing signs and symptoms of
moderate to severe Crohn's disease and maintaining clinical response in adult
patients who have had an inadequate response to conventional therapy. Cimzia
is the only PEGylated anti-TNF alpha (Tumor Necrosis Factor alpha).

"These are important findings as Cimzia(R) shows an extended duration of
response in an induction and maintenance clinical trial of Crohn's disease
patients who have failed infliximab," said study investigator Douglas Wolf,
M.D., Atlanta Gastroenterology Associates, Atlanta, GA. "The study
demonstrates that Cimzia(R) is effective up to 26 weeks in this difficult to
treat patient population."

The primary objective of WELCOME is to assess the clinical efficacy of
Cimzia(R) (400 mg) at week 6 following an induction, in moderate to severe
Crohn's disease patients who have previously received and responded but who no
longer have a sustained response and/or tolerance to infliximab. Primary
efficacy was defined as at least 100 points decrease in the Crohn's Disease
Activity Index (CDAI) versus baseline at week 6. The trial demonstrated that
after the induction period 62 percent of patients achieved response and 39
percent achieved remission. 33 percent responded to treatment by week 2 and 44
percent responded by week 4. By week 26, nearly a third of patients receiving
Cimzia(R) (400 mg) subcutaneously every two or four weeks, respectively,
achieved clinical remission as measured by the CDAI.

No new or unexpected safety signals were observed in this study. Adverse
events were previously reported from the WELCOME study: the most common
adverse events were headache, nasopharyngitis and nausea. The incidence of
serious adverse events (SAEs) was seven percent and the most frequent SAEs
involved gastrointestinal disorders (five percent) and infections and
infestations (2 percent).

Additional data from the WELCOME study presented at DDW, includes:
-- Health-related Quality of Life: Cimzia(R) (400 mg) administered at
every
two or four weeks similarly improved patient-reported health-related
quality of life as measured by the Inflammatory Bowel Disease
Questionnaire (a validated tool assessing bowel symptoms, systematic
symptoms, emotional function and social function) by Week 26.
(Abstract
#S1058)

-- Efficacy Independent of IFX Dosing: Cimzia(R) (400 mg) was efficacious
in rapidly inducing a clinical response in the infliximab-refractory
patient population regardless of the previous dosages of infliximab.
(Abstract #S1064)

"As we continue to study Cimzia(R)'s potential efficacy, we are pleased to be
adding to an impressive body of data that supports the use of Cimzia(R) for a
variety of moderate to severe Crohn's disease patients," said David Robinson,
vice president and general manager of UCB's Immunology Business Unit.

Recently, UCB announced that Cimzia(R) is now available to Crohn's patients in
a pre-filled syringe, developed in partnership with OXO Good Grips(R) for
subcutaneous self-administration once every four weeks after initial dosing.
Cimzia(R), manufactured by UCB, was approved by the U.S. Food and Drug
Administration on April 22, 2008.

About WELCOME
The WELCOME study is a 539 patient Phase IIIb multicenter 26-Week trial
Evaluating the clinical benefit and tolerability of certoLizumab pegol
induCtiOn and Maintenance in patients suffering from Crohn's disease with
prior loss of response or intolErance to infliximab. It consists of an
open-label induction phase (400 mg of Cimzia(R) sub-cutaneously at weeks 0, 2
and 4) and a double-blind maintenance period (400 mg of Cimzia(R) every 2 or 4
weeks from Week 6). The primary endpoint was defined as the rate of response
(defined as a decrease in CDAI score greater than or equal to 100 points from
baseline) at week 6. Remission was defined as a CDAI score of less than or
equal to 150 points. After the induction period, 62 percent of patients
achieved response and 39 percent achieved remission. One-third of patients had
responded to treatment by week 2 (33 percent) and more than forty percent (44
percent) had responded by Week 4.

About Crohn's Disease
Crohn's disease is a chronic, progressive, destructive disorder that causes
inflammation of the gastrointestinal (GI) tract, most commonly at the end of
the small intestine (the ileum) and beginning of the large intestine (the
colon). If not effectively treated, it may result in the need for surgery and
hospitalization. Crohn's disease has been estimated to affect as many as half
a million Americans. People with Crohn's can experience an ongoing cycle of
flare-up and remission throughout their lives. Together with ulcerative
colitis, Crohn's disease is an inflammatory bowel disease (IBD).

About CIMZIA(R) (certolizumab pegol)
Cimzia(R) is the only PEGylated anti-TNF (Tumor Necrosis Factor). Cimzia(R)
has a high affinity for human TNF-alpha, selectively neutralising the
pathophysiological effects of TNF-alpha. Over the past decade, TNF-alpha has
emerged as a major target of basic research and clinical investigation. This
cytokine plays a key role in mediating pathological inflammation, and excess
TNF-alpha production has been directly implicated in a wide variety of
diseases. The U.S. Food and Drug Administration (FDA) has approved Cimzia(R)
for reducing signs and symptoms of Crohn's disease and maintaining clinical
response in adult patients with moderate to severe active disease who have had
an inadequate response to conventional therapy and for the treatment of adults
with moderately to severely active rheumatoid arthritis. Cimzia(R) was
approved in Switzerland for induction of a clinical response and for the
maintenance of a clinical response and remission in patients with active
Crohn's disease who have not responded adequately to conventional treatment in
September 2007. UCB is also developing Cimzia(R) in other autoimmune disease
indications. Cimzia(R) is a registered trademark of UCB PHARMA S.A.

IMPORTANT SAFETY INFORMATION

Patients treated with CIMZIA are at an increased risk for developing serious
infections that may lead to hospitalization or death. Most patients who
developed these infections were taking concomitant immunosuppressants such as
methotrexate or corticosteroids. CIMZIA should be discontinued if a patient
develops a serious infection or sepsis. Reported infections include:

-- Active tuberculosis, including reactivation of latent tuberculosis.
Patients with tuberculosis have frequently presented with disseminated
or extrapulmonary disease. Patients should be tested for latent
tuberculosis before CIMZIA use and during therapy. Treatment for
latent
infection should be initiated prior to CIMZIA use.
-- Invasive fungal infections, including histoplasmosis ,
coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and
pneumocystosis. Patients with histoplasmosis or other invasive fungal
infections may present with disseminated, rather than localized
disease.
Antigen and antibody testing for histoplasmosis may be negative in
some
patients with active infection. Empiric anti-fungal therapy should be
considered in patients at risk for invasive fungal infections who
develop severe systemic illness.

-- Bacterial, viral and other infections due to opportunistic pathogens.

The risks and benefits of treatment with CIMZIA should be carefully considered
prior to initiating therapy in patients with chronic or recurrent infection.
Patients should be closely monitored for the development of signs and symptoms
of infection during and after treatment with CIMZIA, including the possible
development of tuberculosis in patients who tested negative for latent
tuberculosis infection prior to initiating therapy.

Serious and sometimes fatal infection due to bacterial, mycobacterial,
invasive fungal, viral or other opportunistic pathogens has been reported in
patients receiving TNF-blocking agents. Among opportunistic infections,
tuberculosis, histoplasmosis, aspergillosis, candidiasis, coccidioidomycosis,
listeriosis, and pneumocystosis were the most common. Treatment with CIMZIA
should not be initiated in patients with an active infection, including
clinically important localized infections. The risks and benefits of
treatment should be considered prior to initiating therapy in patients with
chronic or recurrent infection, who have been exposed to tuberculosis, who
have resided or traveled in areas of endemic tuberculosis or endemic mycoses,
such as histoplasmosis, coccidioidomycosis, or blastomycosis, or with
underlying conditions that may predispose them to infection.

Patients should be evaluated for tuberculosis risk factors and tested for
latent infection prior to initiating CIMZIA and periodically during therapy.
Patients should be closely monitored for the development of signs and symptoms
of infections during and after treatment with CIMZIA, including development of
tuberculosis in patients who tested negative for latent tuberculosis infection
prior to initiating therapy. CIMZIA should be discontinued if a patient
develops a serious infection or sepsis. Patients who develop a new infection
during treatment with CIMZIA should be closely monitored, undergo a prompt and
complete diagnostic workup appropriate for immunocompromised patients, and
appropriate antimicrobial therapy should be initiated. Appropriate empiric
antifungal therapy should also be considered while a diagnostic workup is
performed for patients who develop a serious systemic illness and reside or
travel in regions where mycoses are endemic.

During controlled and open-labeled portions of CIMZIA studies of Crohn's
disease and other diseases, malignancies (excluding non-melanoma skin cancer)
were observed at a rate (95% confidence interval) of 0.5 (0.4, 0.7) per 100
patient-years among 4,650 CIMZIA-treated patients versus a rate of 0.6 (0.2,
1.7) per 100 patient-years among 1,319 placebo-treated patients. The size of
the control group and limited duration of the controlled portions of the
studies preclude the ability to draw firm conclusions. In studies of CIMZIA
for Crohn's disease and other investigational uses, there was one case of
lymphoma among 2,657 CIMZIA-treated patients and one case of Hodgkin lymphoma
among 1,319 placebo-treated patients. In CIMZIA RA clinical trials
(placebo-controlled and open label) a total of three cases of lymphoma were
observed among 2,367 patients. This is approximately 2-fold higher than
expected in the general population. Patients with RA, particularly those with
highly active disease, are at a higher risk for the development of lymphoma.
The potential role of TNF blocker therapy in the development of malignancies
is not known.

Cases of worsening congestive heart failure (CHF) and new onset CHF have been
reported with TNF blockers. CIMZIA has not been formally studied in patients
with CHF. Exercise caution when using CIMZIA in patients who have heart
failure and monitor them carefully.

Symptoms compatible with hypersensitivity reactions, including angioedema,
dyspnea, hypotension, rash, serum sickness, and urticaria, have been reported
rarely following CIMZIA administration. If such reactions occur, discontinue
further administration of CIMZIA and institute appropriate therapy.

Use of TNF blockers, including CIMZIA, may increase the risk of reactivation
of hepatitis B virus (HBV) in patients who are chronic carriers of this virus.
Some cases have been fatal. Evaluate patients at risk for HBV infection for
prior evidence of HBV infection before initiating CIMZIA therapy. Exercise
caution in prescribing CIMZIA for patients identified as carriers of HBV.
Patients who are carriers of HBV and require treatment with CIMZIA should be
closely monitored for clinical and laboratory signs of active HBV infection
throughout therapy and for several months following termination of therapy. In
patients who develop HBV reactivation, discontinue CIMZIA and initiate
effective anti-viral therapy with appropriate supportive treatment.

Use of TNF blockers, including CIMZIA, has been associated with rare cases of
new onset or exacerbation of clinical symptoms and/or radiographic evidence of
demyelinating disease. Rare cases of neurological disorders, including seizure
disorder, optic neuritis, and peripheral neuropathy have been reported in
patients treated with CIMZIA; the causal relationship to CIMZIA remains
unclear. Exercise caution in considering the use of CIMZIA in patients with
these disorders.

Rare reports of pancytopenia, including aplastic anemia, have been reported
with TNF blockers. Medically significant cytopenia (e.g., leukopenia,
pancytopenia, thrombocytopenia) has been infrequently reported with CIMZIA.
The causal relationship of these events to CIMZIA remains unclear. Advise all
patients to seek immediate medical attention if they develop signs and
symptoms suggestive of blood dyscrasias or infection (e.g., persistent fever,
bruising, bleeding, pallor) while on CIMZIA. Consider discontinuation of
CIMZIA therapy in patients with confirmed significant hematologic
abnormalities.

An increased risk of serious infections has been seen in clinical trials of
other TNF blocking agents used in combination with anakinra or abatacept.
Formal drug interaction studies have not been performed with rituximab or
natalizumab; however because of the nature of the adverse events seen with
these combinations with TNF blocker therapy, similar toxicities may also
result from the use of CIMZIA in these combinations. Therefore, the
combination of CIMZIA with anakinra, abatacept, rituximab, or natalizumab is
not recommended.

Treatment with CIMZIA may result in the formation of autoantibodies and,
rarely, in the development of a lupus-like syndrome. Discontinue treatment if
symptoms of lupus-like syndrome develop.

Do not administer live vaccines or attenuated vaccines concurrently with
CIMZIA.

Interference with certain coagulation assays has been detected in patients
treated with CIMZIA. There is no evidence that CIMZIA therapy has an effect on
in vivo coagulation. CIMZIA may cause erroneously elevated aPTT assay results
in patients without coagulation abnormalities.

In controlled Crohn's clinical trials, the most common adverse events that
occurred in greater than or equal to 5% of CIMZIA patients (n=620) and more
frequently than with placebo (n=614) were upper respiratory infection (20%
CIMZIA, 13% placebo), urinary tract infection (7% CIMZIA, 6% placebo), and
arthralgia (6% CIMZIA, 4% placebo). The proportion of patients who
discontinued treatment due to adverse reactions in the controlled clinical
studies was 8% for CIMZIA and 7% for placebo.
In controlled RA clinical trials, the most common adverse events that occurred
in greater than or equal to 3% of patients taking CIMZIA 200 mg every other
week with concomitant methotrexate (n=640) and more frequently than with
placebo with concomitant methotrexate (n=324) were upper respiratory tract
infection (6% CIMZIA, 2% placebo), headache (5% CIMZIA, 4% placebo),
hypertension (5% CIMZIA, 2% placebo), nasopharyngitis (5% CIMZIA, 1% placebo),
back pain (4% CIMZIA, 1% placebo), pyrexia (3% CIMZIA, 2% placebo),
pharyngitis (3% CIMZIA, 1% placebo), rash (3% CIMZIA, 1% placebo), acute
bronchitis (3% CIMZIA, 1% placebo), fatigue (3% CIMZIA, 1% placebo).
Hypertensive adverse reactions were observed more frequently in patients
receiving CIMZIA than in controls. These adverse reactions occurred more
frequently among patients with a baseline history of hypertension and among
patients receiving concomitant corticosteroids and non-steroidal
anti-inflammatory drugs. Patients receiving CIMZIA 400mg as monotherapy every
4 weeks in RA controlled clinical trials had similar adverse reactions to
those patients receiving CIMZIA 200mg every other week. The proportion of
patients who discontinued treatment due to adverse reactions in the controlled
clinical studies was 5% for CIMZIA and 2.5% for placebo. Please see
accompanying full prescribing information or visit www.Cimzia.com.

About UCB
UCB, Brussels, Belgium (www.ucb.com) is a biopharmaceutical company dedicated
to the research, development and commercialization of innovative medicines
with a focus on the fields of central nervous system and immunology disorders.
Employing approximately 10 000 people in over 40 countries, UCB generated
revenue of EUR 3.6 billion in 2008. UCB is listed on Euronext Brussels
(symbol: UCB).

Forward-Looking Statement
This press release contains forward-looking statements based on current plans,
estimates and beliefs of management. Such statements are subject to risks and
uncertainties that may cause actual results to be materially different from
those that may be implied by such forward-looking statements contained in this
press release. Important factors that could result in such differences
include: changes in general economic, business and competitive conditions,
effects of future judicial decisions, changes in regulation, exchange rate
fluctuations and hiring and retention of its employees.

SOURCE UCB, Inc.

Bert Kelly, Manager, U.S. Communications & Public Relations, UCB Group,
+1-404-784-6303, Bert.Kelly@ucb.com, or Eric Miller, Director, U.S. Corporate
Communications, UCB Group, +1-770-970-8569, Eric.Miller@ucb.com, or Antje
Witte, Vice President, Corporate Communications & Investor Relations, UCB
Group, +32-2-559-9414, Antje.Witte@ucb.com